Federal Register notice: FDA determines that Norflex (orphenadrine citrate) injection and extended-release tablets were not withdrawn from sale for re...
FDA releases the form FDA-483 with 10 observations from an inspection at the Telangana, India-based Aurobindo Pharma Unit IX active pharmaceutical ing...
The FDA Digital Health Center of Excellence publishes a 2022 report on non-device software functions.
FDA publishes a draft guidance to further explain but not change the Voluntary Malfunction Summary Program.
FDA releases the form FDA-483 with 16 observations from an inspection at the Pradesh, India-based Lupin Unit 1 drug manufacturing facility.
FDA publishes a proposed rule to make the investigational new drug annual reports more comprehensive and similar to those in other countries.
FDA publishes a draft guidance on the content of human factor and usability engineering information to be included in medical device marketing submiss...
Two stakeholder associations comment on an FDA draft guidance on general clinical pharmacology considerations for pediatric studies of drugs.
